American Pain Foundation. Dedicated to the elimination of the
undertreatment of pain.

Deadline Approaching:
Voice Your Opinion about REMS for Opioids TODAY

(October 8, 2010)

Submit your opinion and make your voice a part of the official record
about risk evaluation mitigation strategies (REMS) for opioids.
The FDA Docket on REMS closes on Tuesday, October 19, 2010
ACT NOW AND LET YOUR VOICE BE HEARD!

In July, FDA presented its proposal for a class REMS for long-acting
(LA) and extended-release (ER) opioid medications at a joint meeting
of the Anesthetic and Life Support Drugs Advisory Committee and the
Drug Safety and Risk Management Advisory Committee. During the
meeting, FDA gathered feedback and comments from the committees and
the public on its proposal.

FDA currently is analyzing the advice received from the committees and
from public comments. It is not too late to share your opinion! It is
critical that the FDA hears from organizations and individuals
concerned about the availability of and access to pain medicines.
Without careful consideration of the voice of people who live with
pain, REMS have the potential to further limit access to important and
often life-saving medications. The FDA needs to hear your voice!
Please submit your opinion today and encourage others to TAKE ACTION.

Let the FDA know that:

1.  You are opposed to “patient registries” in the
prescription process for opioid analgesic medications.
2.  If the REMS is not going to cover the whole class of opioids,
then there should be no mandatory education requirement.
Many prescribers will simply not prescribe long-acting opioids
if there is an education requirement.  They will likely
substitute short-acting medications which do not have the same
benefits as long-acting opioids.
3.  Access to opioid medications is critical for living a
productive quality of life and that any efforts to curb the
misuse and abuse of these medicines should not interfere with
access to these medicines for people who need them.

ALL SUBMISSIONS TO THE FDA DOCKET MUST INCLUDE THE DOCKET NUMBER WHICH
IS: FDA-2009-N-0143.

RESPONSES CAN BE SUBMITTED ELECTRONICALLY AT:
http://action.painfoundation.org/site/R?i=tmrRXEHq8CpSYx6YgC5lNA..

Responses can be sent by regular mail (but must be received by October
19th) at: FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852

Once the committees’ and the public’s comments have been
thoroughly analyzed, FDA may issue a REMS request letter to the
appropriate sponsors. For more information, click here.
http://action.painfoundation.org/site/R?i=2W_jMt8oogVFA1Igcm13OQ..

Read the latest about how REMS has the potential to affect the lives
of millions of people who live with pain and the health care
professionals who care for them
http://action.painfoundation.org/site/R?i=E8t12-vnN2x5bgpXpWT6_g..

and visit the REMS FAQ.
http://action.painfoundation.org/site/R?i=D_AWEBUoE00aeEiRkGEj_w..

Thank you for helping protect the rights of people with pain!

American Pain Foundation